Kornimate/medical-research-clean huggingface dataset:
effectiveness of actisight™ needle guidance system in patients undergoing ct-guided procedures

Conditions: Lung Diseases; Liver Diseases

Summary: to assist in guiding a rigid interventional instrument percutaneously, to a designated point within the body by means of ct visualization.

the actisight™ needle guidance system is an optical navigation system designed to assist physicians performing percutaneous interventions under ct guidance. the system allows the user to select an obstacle free path to a target lesion based on pre-procedure ct images, and then provides real-time information for guiding the interventional tool towards the target along the selected path. the actisight™ needle guidance system employs a miniature video camera mounted on the needle and a reference pad attached to the skin to register the needle into the ct image space, and thus, track the needle advance towards the target. ct scans are used as needed to verify the location of the needle. the primary objective of this study is to demonstrate the effectiveness of the actisight™ needle guidance system in assisting in ct-guided percutaneous procedures.

Eligibility criteria:
inclusion criteria: * male or female subjects, 18 years of age or older at the time of enrollment. * subjects meeting all medical conditions for percutaneous ct guided. procedures in the chest, abdomen or pelvic, with safe path to lesion. * written informed consent to participate in the study. * ability to comply with the requirements of the study procedures. exclusion criteria: * having co-morbidities that would clinically preclude them from an image guided procedure as determined by the operating physician. * significant coagulopathy that cannot be adequately corrected. * patients who have a medical contraindication to sedation (lidocaine allergy). * pregnancy or lactation. * participation in an investigational trial within 30 days of enrollment.

Keywords: thorax abdomen
lifu for treatment for refractory opioid use disorder

Conditions: Opioid Use Disorder

Summary: this is a randomized, double-blind, sham-controlled, partial crossover study investigating lifu targeting the nac and vc for participants with severe, treatment refractory oud.

the overall objective of this study is to assess the safety, tolerability, and feasibility of using low intensity focused ultrasound (lifu) to treat opioid use disorder (oud) as well as investigate the potential impact on substance use and risk factors associated with drug use recurrence.

Eligibility criteria:
inclusion criteria: * aged 22 - 60 years at time of enrollment. * fulfill current dsm-5 (american psychiatric association diagnostic and statistical manual of mental disorders, 5th ed, 2013) diagnostic criteria for severe oud with at least a 2-year history. * women of reproductive potential must have negative pregnancy test and agree to use acceptable forms of contraception. exclusion criteria: * unable to undergo mr-imaging because of non-mr compatible implants (e.g., pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent make-up or small metal fragments in the eye that welders and other metal workers may have), or if candidates are uncomfortable in small spaces (have claustrophobia) or cannot lie comfortably on their back for 2-3 hours. * history of any clinically significant neurological disorder (e.g., brain surgery, tumors, uncontrolled epilepsy, or any others deemed clinically significant by the investigator). * history of stroke or brain lesion in the targeted brain region (the nac, ventral striatum, or vc). * implanted neurostimulators (e.g., vagus nerve stimulator, spinal cord stimulator, dbs). * documentation of clinically significant mri abnormality indicative of a neurological condition or abnormality that may jeopardize the participant's safety, study conduct, or confound the participant's diagnostic assessments. * more than 30% of the skull area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp. * subject with chronic pulmonary disorders e.g. severe emphysema, pulmonary vasculitis, or other causes of reduced pulmonary vascular cross-sectional area. * subject with impaired renal function with estimated glomerular filtration rate \<30 ml/min/1.73m2 * hepatic function laboratory values which are \> 1.5 times the upper limit of normal unless deemed not clinically significant by a study investigator. * past or present diagnosis of schizophrenia or psychotic disorder. * subject unwilling to attempt abstinence from illicit substance use during the course of the study. * unable to speak, read and understand english. * subject is considered to be a poor surgical or study candidate, which may include, but is not limited to the following: any medical, social, or psychological problem that could complicate the required procedures and evaluations of the study in the judgment of the investigator.
vestibular function and vestibular rehabilitation in sshl with vertigo

Conditions: Vestibular Disorder

Summary: to evaluate the vestibular function and vestibular rehabilitation in sudden sensorneural hearing loss(sshl) with vertigo

approximately 5-20 per 100,000 persons are afflicted with sshl annually, and nearly 20-60% of sshl patients complain of simultaneous vertigo.the aim of this study was to evaluate the prevalence of vestibulocochlear lesions in sudden sensorneural hearing loss(sshl) with vertigo, as well as the role of vestibular rehabilitation in the prognosis of sshl with vertigo.

Eligibility criteria:
inclusion criteria: 1. a rapid onset sensorineural hearing loss of more than 30 db for at least three contiguous audiometric frequencies within a period of 3 days, according to standard aao - hns; 2. within 10 days from onset; 3. without other virus infectious disease within three months. exclusion criteria: 1. bppv; meniere's disease and vestibular migraine. 2. with certain known etiology, including acoustic neuroma, heart cerebrovascular accident, injury, hunt syndrome, etc
early detection of pancreatic adenocarcinoma (pdac) using a panel of biomarkers

Conditions: Pancreatic Ductal Adenocarcinoma

Summary: urine and blood samples are being collected from patients with and without diseases of the pancreas. these samples will be tested with the aim of developing an accurate way of diagnosing diseases of the pancreas using the results.

the main aim of this research study is to establish the accuracy of a urinary biomarker panel (lyve1, reg1b, tff1), and affiliated pancrisk score alone or in combination with plasma ca19-9 for early detection of pancreatic ductal adenocarcinoma (pdac). samples will be collected from symptomatic individuals with suspected pancreatic cancer, and asymptomatic subjects at risk of developing pdac. the results of urine biomarker and ca19-9 analysis carried out on these samples will be compared to the imaging and, where available, histopathology data, which will inform the development of a predictive model to detect pdac earlier.

Eligibility criteria:
inclusion criteria (symptomatic patients): * able and willing to give informed consent * ≥18 years old * suspected pancreatic diseases with symptoms including, but not limited to, diarrhoea, back pain, abdominal pain, nausea, vomiting, constipation or new onset diabetes exclusion criteria (symptomatic patients): * current or prior treatment (chemotherapy, radiotherapy, surgical resection, biological therapy, and immunotherapy) for any malignancy other than basal cell carcinoma within 5 years of enrolment. asymptomatic participants will be identified through the europac registry and will fulfil europac's eligibility criteria.

Keywords: biomarker pdac pancreatic cancer ca19-9 urine
preventive efficacy and safety of rebamipide on nsaid induced mucosal toxicity

Conditions: Rheumatoid Arthritis; Osteoarthritis; Ankylosing Spondylitis

Summary: to prove that the efficacy and safety of mucosta® (rebamipide) is non-inferior to those of cytotec® (misoprostol), in terms of prevention of nsaid-induced gastric ulcer.


Eligibility criteria:
inclusion criteria: 1. signed written informed consent after being informed of the clinical trial 2. males or females 19 years of age 3. intake of any brand of nsaids in more than half of daily dose for at least the previous 4 weeks. exclusion criteria: 1. necessary to proceed in concomitant treatment with epileptic medications, anti-chollinergics, prokinetics, sucralfate 2. presence or history of allergic drug reaction to the following medications; rebamipide, misoprostol, nsaids designated to the protocol

Keywords: patients with rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis or any other arthritis-like disease requiring continuous nsaids therapy
medical staff: higher risk for gastrointestinal polypoid lesions

Conditions: the Incidence of Gastrointestinal Diseases Diagnosed by Endoscopy in Physicians and General Population

Summary: this is a single center, retrospective, propensity score-matched analyzed study. patients who underwent gastroscopy and colonoscopy for physical examination in qilu hospital of shandong university, china, from january 2017 to september 2018, were retrospectively reviewed to compare the incidence of gastrointestinal diseases diagnosed by endoscopy between physicians and general population.

this is a single center, retrospective, propensity score-matched analyzed study. patients who underwent gastroscopy and colonoscopy for physical examination in qilu hospital of shandong university, china, from january 2017 to september 2018, were retrospectively reviewed.to compare the incidence of gastrointestinal diseases diagnosed by endoscopy between physicians and general population.

Eligibility criteria:
inclusion criteria: - patients who underwent gastroscopy and colonoscopy for physical examination in qilu hospital from january 2017 to september 2018 exclusion criteria: - subjects who had a history of gastrointestinal surgery or subjects who did not finish the endoscopic examination were excluded
risk factors,prevention and outcomes for ci-aki in patients undergoing pci at intensive care unit(precise-icu)

Conditions: CIN

Summary: a retrospective, observational study included all consecutively critically ill patients undergoing percutaneous coronary intervention(pci) at intensive care unit (icu) in fujian provincial hospital from january 1st 2012 to december 31st 2018. the aim was to determine the incidence,risk factors,prophylactic strategy and outcomes of ci-aki in critically ill patients undergoing pci.


Eligibility criteria:
inclusion criteria: * critically ill patients undergoing pci at icu exclusion criteria: * pregnancy * lactation * end-stage renal disease (egfr \<15 ml/min/1.73 m2) * long-term dialysis treatment * intravascular administration of contrast medium within the last 7 or 3 days postoperatively
evaluating the preliminary efficacy and safety of js207 in nsclc after progression following platinum-based chemotherapy and immunotherapy

Conditions: Advanced NSCLC

Summary: this is a single-arm, open phase ii clinical trial evaluating the safety, tolerability,and preliminary efficacy of js207 in nsclc after progression following platinum-based chemotherapy and immunotherapy


Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed locally advanced (stage iiib/iiic) nsclc that is not amenable to radical surgery or radical radiochemotherapy, or metastatic or recurrent nsclc. 2. patients with incurable locally advanced or metastatic or recurrent nsclc who have experienced treatment failure with first-line treatment using a pd-1/pd-l1 inhibitor combined with platinum-based doublet chemotherapy (except docetaxel) or treatment failure with sequential first-line treatment using a pd-1/pd-l1 inhibitor and platinum-based doublet chemotherapy (except docetaxel) may be eligible. previous treatments include anti-vegf monoclonal antibody. for patients with operable early stage or locally advanced nsclc who have received adjuvant and/or neoadjuvant therapy, radical radiotherapy or radiochemotherapy, disease progression or recurrence within 6 months after the last anti-tumor therapy, adjuvant/neoadjuvant/radiochemotherapy is considered as first-line therapy. 3. subjects must have at least one measurable lesion according to recist v1.1. exclusion criteria: 1. histopathologically or cytopathologically confirmed to have combined neuroendocrine (including small cell lung cancer, large cell neuroendocrine carcinoma, etc.) component. 2. sensitivity mutation of egfr or alk fusion; known ros1 fusion, braf v600e mutation, met 14 exon skip mutation, ret fusion, etc. gene mutation. the egfr and alk fusion status must be tested in patients with non-squamous cell carcinoma (the mutation status must be confirmed based on the tissue test if the blood test is negative); the genetic test is not mandatory for patients with squamous cell carcinoma. 3. tumor encircles important blood vessels or has obvious necrosis and air space, and the investigator considers that it may cause hemorrhage risk.
outcomes of patients who survived treatment on an intensive care unit for covid-19 in england and wales

Conditions: Covid19; Myocardial Infarction; Stroke; Critical Illness; Heart Failure; Deep Vein Thrombosis; Pulmonary Embolism; Renal Failure

Summary: this retrospective cohort study aims to characterise outcomes for patients treated on an intensive care unit (icu) with covid-19 in england and wales, one year after discharge from hospital. outcomes will be compared with patients admitted as an emergency to an icu for other conditions. the study will use existing national audit data linked to routine healthcare datasets.

across england and wales, over 10,000 patients have been treated for severe coronavirus disease 2019 (covid-19) on an intensive care unit. around 60% survived to leave hospital. it is unknown how survivors' severe covid-19 infection, or the treatment they received on the intensive care unit, will affect their long-term health. understanding what happens to these patients can help ensure they receive suitable care from their general practitioner (gp) and other national health service (nhs) services after they leave hospital. this study will follow up survivors for 1 year after discharge from hospital. the investigators will use data collected by the intensive care national audit and research centre (icnarc) to identify patients who were treated on an icu for covid-19. the investigators will then use nhs data to see whether these patients were readmitted to hospital and why. information from the office of national statistics will identify whether patients died. by linking different sources of patient data, the investigators will estimate the health risks faced by survivors of severe covid-19. these risks will be compared to those in patients treated on an icu for other conditions.

Eligibility criteria:
inclusion criteria: * age 16 years or over * admitted to an adult, general icu in england or wales as an emergency (unplanned) * admitted to icu for either: a) confirmed covid-19 between 1st january to 1st july 2020 or b) without confirmed covid-19 between 1st july 2016 and 1st july 2020- exclusion criteria: * patients who died in hospital after treatment on an icu
study of ivacaftor in cystic fibrosis subjects aged 12 years and older homozygous for the f508del-cftr mutation

Conditions: Cystic Fibrosis

Summary: the purpose of this study was to evaluate the safety and efficacy of ivacaftor in participants with cystic fibrosis (cf) who were aged 12 years or older and were homozygous for the f508del-cf transmembrane conductance regulator (cftr) mutation. ivacaftor is a potent and selective cftr potentiator of wild-type, g551d, f508del, and r117h forms of human cftr protein. potentiators are pharmacological agents that increase the chloride ion transport properties of the channel in the presence of cyclic adenosine monophosphate (amp)-dependent protein kinase a (pka) activation.

this study investigated the effects of ivacaftor in participants with cystic fibrosis (cf) \>=12 years of age with a forced expiratory volume in 1 second (fev1) \>=40 percent (%) predicted. this study was conducted in 2 parts. * part a of this study was a randomized, double-blind, placebo-controlled, parallel-group evaluation of participants with cf who were aged 12 years or older and were homozygous for the f508del-cftr mutation. * part b of this study was an open-label extension of part a, enrolling participants who completed part a and met pre-specified endpoint criteria, and explored the safety and efficacy of ivacaftor over long-term treatment in participants with cf aged 12 years or older who were homozygous for the f508del-cftr mutation.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of cystic fibrosis (cf) and homozygous for f508del-cftr mutation * forced expiratory volume in 1 second (fev1) of at least 40% of predicted normal for age, gender, and height * willing to use at least 2 highly effective birth control methods during the study * no clinically significant abnormalities that would have interfered with the study assessments, as judged by the investigator * able to understand and comply with protocol requirements, restrictions, and instructions and likely to complete the study as planned, as judged by the investigator exclusion criteria: * history of any illness or condition that might confound the results of the study or pose an additional risk in administering study drug to the subject * acute respiratory infection, pulmonary exacerbation, or changes in therapy for pulmonary disease within 4 weeks of day 1 of the study * history of alcohol, medication or illicit drug abuse within one year prior to day 1 * abnormal liver function \>=3 x the upper limit of normal * abnormal renal function at screening * history of solid organ or hematological transplantation * pregnant or breast-feeding (for women) * ongoing participation in another therapeutic clinical study or prior participation in an investigational drug study within 30 days prior to screening * previous participation in a vx-809 study * used inhaled hypertonic saline treatment * concomitant use of any inhibitors or inducers of cytochrome p450 3a4 (cyp3a4)

Keywords: fibrosis pancreatic diseases digestive system diseases lung diseases respiratory tract diseases genetic diseases, inborn infant, newborn, diseases pathologic processes
effects of cranberry juice on risk factors for cardiovascular disease

Conditions: Atherosclerosis

Summary: this study is being done to determine if the use of double strength cranberry juice in daily diet will improve endothelial function.

study participants will be randomized assigned to drink either placebo (a drink that looks and tastes like cranberry juice, but does not contain cranberry juice) or a double strength ocean spray light cranberry juice cocktail for four months.

Eligibility criteria:
inclusion criteria: * subjects over the age of 18 years old with known or suspected cardiovascular disease including documented cad by cardiac catheterization, and multiple cardiovascular risk factors will be included, regardless of severity of endothelial dysfunction or previous history of cardiovascular events. * subjects with no known history of cardiac disease will also be eligible to participate. * subjects must demonstrate endothelial dysfunction via the rh-pat test (an rh-pat score of less than 2.0) to continue participating in this study. exclusion criteria: * patients will be excluded if they have confounding factors including, but not limited to, history of renal or liver failure, or relevant food allergies (cranberries, etc.).
treatment of diabetic retinopathy with open-label anecortave acetate sterile suspension (15 mg)

Conditions: Diabetic Retinopathy

Summary: the purpose of this study is to provide compassionate use of anecortave acetate sterile suspension of 15 mg for a series of five patients as a means to control diabetic retinopathy.


Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of patients with diabetic retinopathy. 2. patients must be at least 18 years of age. 3. visual acuity of 20/30 to 20/320 in study eye on the early treatment of diabetic retinopathy study (etdrs) visual acuity chart 4. visual acuity of 20/800 or better in fellow eye on the etdrs visual acuity chart exclusion criteria: 1. patient with significantly compromised visual acuity in the study eye due to concomitant ocular conditions. 2. patients who have undergone intraocular surgery within the last 2 months. 3. patient participating in any other investigational drug study. 4. use of an investigational drug or treatment related or unrelated to their condition within 30 days prior to receipt of study medication. 5. inability to obtain photographs to document choroidal neovascularization (cnv) (including difficulty with venous access). 6. patient with significant liver disease or uremia. 7. patient with known adverse reaction to fluorescein and indocyanine green or iodine. 8. patient has a history of any medical condition which would preclude scheduled visits or completion of study 9. patient has had insertion of scleral buckle in the study eye 10. patient has received radiation treatment 11. patient is on anticoagulant therapy with the exception of aspirin 12. patient is pregnant or nursing.
open-label extension study to evaluate the long-term safety and tolerability of aficamten in adults with hcm

Conditions: Symptomatic Hypertrophic Cardiomyopathy (HCM)

Summary: the purpose of this study is to collect long-term safety and tolerability data for aficamten.


Eligibility criteria:
inclusion criteria: * completion of a cytokinetics trial investigating aficamten * lvef ≥ 55% at the screening visit exclusion criteria: * has received treatment with mavacamten: (a) within 56 days prior to dosing and (b) has not received approval for participation from the medical monitor. * has participated in another investigational device or drug study or received an investigational device or drug \< 1 month (or 5 half-lives for drugs, whichever is longer) prior to screening. other investigational procedures while participating in this study are not permitted. * since completion of a previous trial of aficamten has: * developed new-onset paroxysmal or permanent atrial fibrillation requiring rhythm restoring treatment (eg, direct-current cardioversion, ablation procedure, or antiarrhythmic therapy) \ 30 days * undergone septal reduction therapy (surgical myectomy or transcatheter alcohol ablation) * had a confirmed lvef \< 40% with an associated dose interruption during participation in a prior study with aficamten * history of implantable icd placement within 30 days prior to screening.

Keywords: obstructive hypertrophic cardiomyopathy ohcm ck-3773274 ck-274 non obstructive hypertrophic cardiomyopathy nhcm hcm hypertrophic cardiomyopathy aficamten redwood-ole cy 6022 forest-hcm forest